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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K261859
Device Name Electric Scooter (FDB08, FDB08A, FDB12)
Applicant
Anhui JBH Medical Apparatus Co., Ltd.
# 116 Qicang Rd., Industrial District, Ming Guang City
Chuzhou,  CN 239000
Applicant Contact Yuanwei Wei
Correspondent
Huide Medical Technology Service Group Co., Ltd.
Rm. 703, Bldg. 16, S. Bank Plz., Exhibition Bay
Zhancheng Community, Fuhai St., Bao'An District
Shenzhen,  CN 518053
Correspondent Contact Amos Zou
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/04/2026
Decision Date 09/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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